Study of effect of calcitriol in preventing contrast induced nephropathy among patients with kidney dysfunction undergoing coronary angiography or interventions
Effect of calcitriol in preventing contrast induced nephropathy among patients with renal dysfunction undergoing coronary angiography or intervention
Design
A double blind randomized control trial, with a parallel group design of 236 patients, enrolled between September 2016 through July 2017, and followed for one year
Settings and conduct
sampling was done in educational hospitals of Shahid Beheshti University of Medial Science. patients and doctors were blind about drug and placebo coding
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Adults above 18 years old referring to Taleghani hospital for PCI with Scr ≥ 1.3 mg/dl
or GFR ≤ 60ml/min
Exclusion criteria:
Active metabolic bone dis, Allergy to vitamin D, vitamin supplementation through 7 days ago, dialysis ,severe hepatic dis.
Intervention groups
patients over 18 years old that were admitted in educational hospitals of shahid beheshti university of medical science in two groups of placebo and calcitriol
Main outcome variables
cystatin C and glumerolar filtration Rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160412027346N7
Registration date:2019-05-13, 1398/02/23
Registration timing:retrospective
Last update:2019-05-13, 1398/02/23
Update count:0
Registration date
2019-05-13, 1398/02/23
Registrant information
Name
Shadi Ziaie
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8887 3704
Email address
shadiziaie@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2017-09-22, 1396/06/31
Actual recruitment start date
2016-06-21, 1395/04/01
Actual recruitment end date
2017-09-06, 1396/06/15
Trial completion date
2017-09-06, 1396/06/15
Scientific title
Study of effect of calcitriol in preventing contrast induced nephropathy among patients with kidney dysfunction undergoing coronary angiography or interventions
Public title
calcirtiol effect in contrast induced nephropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adults above 18 years old referring to Taleghani hospital for PCI with Scr ≥ 1.3 mg/dl or GFR ≤ 60ml/min
Exclusion criteria:
Active metabolic bone dis, Allergy to vitamin D, vitamin supplementation through 7 days ago, dialysis ,severe hepatic disease.
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
236
More than 1 sample in each individual
Number of samples in each individual:
2
Two blood samples in 24 hours interval were taken from patients
Actual sample size reached:
236
More than 1 sample in each individual
Actual sample size in each individual:
2
Two blood samples in 24 hours interval were taken from patients
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization
by excel software
Blinding (investigator's opinion)
Double blinded
Blinding description
Drug an placebo were similar in shape and packaging. code A belongs to placebo and code B belongs to drug. Only main researcher known the code. cardiologists that were blind about coding system, gave drug or placebo to patients
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Yaman Ave
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2016-04-03, 1395/01/15
Ethics committee reference number
IR.SMMU.PHNM.1395.503
Health conditions studied
1
Description of health condition studied
effect of calcitriol in preventing contrast induced nephropathy in patients with renal function undergoing coronary angiography or intervention.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
serum level of cystatin C and its changes
Timepoint
at the beginning of angiography and 24 hours later
Method of measurement
using lab kit with considering elisa method, serum concentration of cystatin c was measured.
Secondary outcomes
1
Description
serum level of creatinine
Timepoint
at baseline and 24 h after intervention
Method of measurement
using lab kit with turbidimetry method.
Intervention groups
1
Description
Intervention group: Adults above 18 years old referring to educational hospital for PCI with Scr ≥ 1.3 mg/dl or GFR ≤ 60ml/min were enrolled in study . patients receive 3 calcitriol tabs 3 and 12 hours before procedure .
Category
Treatment - Drugs
2
Description
Control group: in control group , Adults above 18 years old referring to educational hospital for PCI with Scr ≥ 1.3 mg/dl or GFR ≤ 60ml/min were enrolled in study patients receive 3 placebo tabs 3 and 12 hours before procedure
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
educational hospitals of shahid beheshti university of medical science
Full name of responsible person
solmaz hassani
Street address
Yaman Ave
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8887 3704
Email
s_hassani_85@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
shadi ziaie
Street address
Yaman Ave
City
tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8887 3704
Email
s_hassani_85@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
50
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
shadi ziaie
Position
resident of clinical pharmacy
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Yaman Ave
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8887 3704
Email
s_hassani_85@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
shadi ziaie
Position
assisstant professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Yaman Ave
City
tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8887 3704
Email
s_hassani_85@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shadi Ziaie
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Niayesh Highway, Valiasr Ave, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8887 3704
Fax
Email
shadiziaie@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be accessible in excel form
When the data will become available and for how long
After publishing the article
To whom data/document is available
Academic members can have access to data.
Under which criteria data/document could be used
for doing similar research, data can be used.
From where data/document is obtainable
they can refer to first author
What processes are involved for a request to access data/document
one week after sending email, data file will be sent